Limited Competition Renewal for the Continuation of the Liver Cirrhosis Network: Clinical Research Centers (U01 Clinical Trial Required)

The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), has issued a limited competition funding opportunity to renew support for Clinical Research Centers participating in the Liver Cirrhosis Network (LCN). This opportunity (U01 Clinical Trial Required) seeks to continue the pivotal work initiated under the prior RFA-DK-20-003 and is released in tandem with RFA-DK-26-309 for the associated Scientific Data Coordination Center (SDCC). LCN is a major NIH initiative aimed at improving clinical understanding and outcomes for patients with liver cirrhosis by leveraging long-term cohort studies and interventional trials. Cirrhosis, resulting from diverse chronic liver diseases such as hepatitis, metabolic conditions like NASH, autoimmune hepatitis, and alcoholic liver disease, remains a leading cause of morbidity and mortality in the United States. The LCN was established to address the urgent need for research into fibrosis progression and clinical complications of cirrhosis. Among its key efforts are the LCN Cohort Study (a longitudinal analysis of compensated cirrhosis) and the LCN RESCU trial (a randomized study evaluating rosuvastatin’s efficacy and safety). The renewed funding will support the completion of enrollment in these studies and further data and biospecimen collection. Eligible applicants include U.S.-based organizations that were prior recipients under RFA-DK-20-003. Only one application per institution is allowed. The Clinical Centers funded under this program are required to participate in network-wide protocols, collaborate with the SDCC, and collect high-quality clinical, biochemical, and imaging data. They must also engage in biospecimen collection and retention of enrolled patients, with an emphasis on inclusive representation, including participants with HIV. Each application must also include a distinct Scientific Exploratory Specific Aim using LCN’s biospecimen or data resources, though no budget should be proposed for this aim. The total funding available for FY 2026 is $3.3 million, with up to 10 awards expected. There is no specified budget limit per award, but budgets must reflect actual project needs. Awards may be for up to 5 years. Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or institutional S2S platforms. The earliest submission date is February 6, 2026, and the first application deadline is March 6, 2026. A second deadline is set for March 8, 2027. Applications must be received by 5:00 PM local time and late submissions will not be accepted. Evaluation will follow standard NIH peer review, assessing the significance, innovation, feasibility, and the investigators’ expertise and environment. Clinical centers are also expected to demonstrate efficient use of EMR systems for recruitment. Program oversight will be conducted through a Steering Committee and an independent Data and Safety Monitoring Board. All funded centers must commit to transparent data sharing per NIH’s Data Management and Sharing Policy, and final research data and biospecimens will be deposited into the NIDDK repository for future public access. Contact for scientific and research questions is NIDDK's Division of Digestive Diseases and Nutrition ([email protected]), while grant management inquiries should be sent to [email protected]. The opportunity expires March 9, 2027.

Ensure distinct Exploratory Aim; avoid overlapping with LCN Cohort/RESCU trials; confirm NIH registration early; leverage EMRs for recruitment; plan biospecimen tracking